Glaxo's GarnierIs Taking the Heat
Defending Safety of Avandia Preoccupies,But Doesn't Consume, Drug Company's CEO
By JEANNE WHALENJuly 9, 2007; Page B1
Jean-Pierre Garnier, chief executive of GlaxoSmithKline PLC, has been in the hot seat since May, when an article in the New England Journal of Medicine raised concerns about the safety of the diabetes treatment Avandia, his company's second-biggest selling drug.
In the article, cardiologist Steven Nissen analyzed 42 past clinical trials of Avandia -- an approach known as a meta-analysis -- and concluded that patients taking the drug may be at a higher risk for heart attacks than patients taking other drugs. Since then, Avandia prescriptions have fallen sharply, and Glaxo's stock price has plummeted.
Dr. Garnier is now trying to fight research with research. He says Glaxo performed its own meta-analysis of Avandia before Dr. Nissen's -- and also found a risk of heart attack. But the risk was very slight, and was outweighed by other evidence showing that Avandia is as safe for the heart as other diabetes drugs, Dr. Garnier says. The Food and Drug Administration is now carrying out its own meta-analysis and will convene a panel of medical advisers on July 30 to weigh the evidence.
Dr. Garnier has faced safety crises before. In 2004, medical experts raised concerns that Glaxo's Paxil and other antidepressants could induce suicidal thinking and behavior in children, leading the FDA to add strong warnings to the drugs.
In an interview in Glaxo's Philadelphia office, Dr. Garnier discussed such topics as managing the Avandia crisis, the pricing of HIV drugs, serving poor communities and what he wants to accomplish before stepping down as CEO in May 2008. Excerpts follow.
WSJ: Has Glaxo done everything it could to study Avandia and communicate its risks to the public?
Dr. Garnier: We're not perfect, I'm sure. With 20-20 hindsight we could have done more. But I have to say in the case of Avandia, you see that we were diligent from the day of the launch to start to study the drug in some depth in [clinical] studies and then we did the meta-analysis a year ahead of Dr. Nissen. As soon as we found out that there was at least a question raised by the meta-analysis, we immediately did the epidemiology study with 30,000 patients that came out absolutely squeaky clean and supportive of Avandia. So you look at the totality, Avandia is by far the most studied diabetic agent on the market today. So sure, maybe we could do more, but frankly the record is very good. Not only have we studied this drug right, left and center, but also we have been transparent, informed everybody.
WSJ: What feedback are you getting from doctors about Avandia?
Dr. Garnier: Doctors are worried about being sued for putting patients on Avandia and things like this. But overall, they are staying behind Avandia. Very few patients actually are switching off their medication. But some have.
WSJ: Are doctors more concerned about liability risk when putting new patients on the drug?
Dr. Garnier: Physicians are naturally gun-shy about putting new patients on. The reality is, and we have the data, they're putting fewer new patients on it. We've just run a big survey of physicians, and they're playing back again the two key points: "Most of my patients have not switched, and I have no intention of switching them. However, as far as putting new patients on Avandia, I'm putting far fewer than before, and I'm waiting to see what the FDA has to say."
WSJ: Does the safety flap take up your entire day?
Dr. Garnier: Pretty much, 24-7. This is a very unpleasant event. But on the other hand this is not my first one. I've been there before. My job is to manage the company through the crisis.
WSJ: How do you do that?
Dr. Garnier: We have crisis-management phone calls every day. These things don't get done without a lot of coordination.
WSJ: Glaxo recently donated 50 million pandemic flu vaccines to the World Heath Organization. What's the story?Dr. Garnier: It's probably the largest vaccine donation ever. The company could have sold possibly those 50 million units. They [Glaxo] decided to set them aside because frankly those countries are not going to buy any pandemic vaccine. Some of them have no commitment to health care.Let's call a cat a cat. They'll buy a lot of other things including Kalashnikovs before they allocate enough money for health care in their own countries. [Some] are committed to better health care but [pandemic flu] never makes their top 10 list because they have humongous problems. They have HIV, and they have this and that. So putting resources aside for a maybe problem doesn't work out to their top priority.WSJ: How has Glaxo changed its HIV-drug pricing in the developing world since you started running the company?
Dr. Garnier: I always wanted to have access as part of the DNA of the company. I don't look at those things as philanthropic undertakings. Even Tykerb -- we just introduced this breast-cancer treatment in the U.S. It's a very expensive product for the average person. We provide funding and subsidies for people up to an income level of $100,000 per family. It's intertwined with the purely commercial pricing. I wanted that. I never wanted to just close my eyes to the fact that 80% of the population won't be able to afford the drugs. Because that's the truth -- 80% of the market for pharmaceuticals comes from 20% of the world-wide population. I'm not going to be CEO of a company that just works for rich countries. And even within rich countries, by the way, you have holes in the safety net that are part of the equation.
WSJ: What has that meant in HIV?
Dr. Garnier: To me, it became very obvious that we had to go much further than to give discounts [on drugs]. We had to make basically a philosophical statement that for the very poor countries of this world, we were going to sell our drugs without making a profit, completely not for profit. And overnight we did this. And that allowed the consumption of HIV drugs in Africa to increase dramatically, exponentially. Overnight we went from very little to hundreds and hundreds of millions of tablets. Then we went one step further and said, why don't we give licenses to generic companies [to make our drugs], particularly local companies. Maybe they can make it even cheaper.
WSJ: What are the main things Glaxo has done to provide better access [to HIV drugs] and what's been the effect?
Dr. Garnier: What we sell at this not-for-profit price corresponds to roughly a million patients being treated, mostly in Africa. We dropped the price, helped with access -- that is, we have a number of community support programs. Because treating people who have HIV is not a simple thing.
WSJ: What are you doing? Opening clinics? Hiring doctors?
Dr. Garnier: No, we don't own the infrastructure but we've supported clinics. Not just with money -- with advice, sending doctors.
WSJ: Do you do much licensing for production of your drugs in middle-income countries like Thailand?
Dr. Garnier: No, no, no. Middle-income countries should pay a fair price for our drugs. They certainly can use some of their resources to pay a fair price, which is clearly an intermediate price between the lowest and the highest -- we try to price according to standard of living.WSJ: You're retiring next year. What more do you want to do?
Dr. Garnier: No. 1 is deliver the pipeline. We have a very exciting, high-quality, deep, dense, innovative pipeline of late-stage drugs. So let's make sure we deliver, and those drugs pass the last hurdle and get launched.